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Xilio Therapeutics is a clinical-stage biotechnology company discovering and developing tumor-activated immuno-oncology therapies. The company is using its proprietary tumor-activation platform to build a pipeline of novel, tumor-activated molecules, including antibodies, cytokines, bispecifics, and cell engagers, which are designed to optimize the therapeutic index and localize anti-tumor activity within the tumor microenvironment. XTX301 is currently being evaluated in a Phase 1 dose escalation trial in patients with advanced solid tumors.

“Xilio’s novel tumor-activation platform naturally complements Gilead’s clinical development program in difficult-to-treat cancers and expands our focus in immuno-oncology,” said Bill Grossman, MD, PhD, Senior Vice President, Oncology Clinical Development, Gilead Sciences. “We believe IL-12 has the potential to treat a broad range of tumor types and are excited to partner with Xilio to advance XTX301, a tumor-activated IL-12, as a monotherapy and a combination therapy across a variety of solid tumors.”

“Gilead’s confidence in our tumor-activated technology, combined with their deep expertise in developing and commercializing novel immuno-oncology products, will enable us to accelerate and expand the development of XTX301, our tumor-activated IL-12,” said René Russo, Pharm.D., President and Chief Executive Officer of Xilio. “We look forward to collaborating with Gilead as we seek to deliver on the potential for XTX301 to provide a meaningful benefit for a range of tumor types, including immunologically cold tumors, while overcoming the severe toxicities historically associated with IL-12.”

Under the terms of the agreement, Xilio granted Gilead an exclusive global license to develop and commercialize XTX301, Xilio’s tumor-activated IL-12. Xilio will receive $43.5 million in upfront payments, including a cash payment of $30 million and an initial equity investment by Gilead of $13.5 million in Xilio common stock at a premium. Xilio will be eligible to receive up to $604 million in additional contingent payments, including additional equity investments by Gilead, a transition fee and specified development, regulatory and sales-based milestones. Xilio will also be eligible to receive tiered royalties ranging from high single digits to mid-teens on annual global net product sales.

Xilio will be responsible for conducting clinical development of XTX301 in the ongoing Phase 1 clinical trial through dose expansion. Following the delivery by Xilio of a specified clinical data package for XTX301, Gilead can elect to transition responsibilities for the development and commercialization of XTX301 to Gilead, subject to the terms of the agreement and payment by Gilead of a $75 million transition fee. Prior to the potential transition fee, Xilio is eligible to receive up to a total of $29 million in additional equity investments and a development milestone payment.

Gilead does not exclude acquired IPR&D expenses from its non-GAAP financial measures. This transaction is expected to reduce Gilead’s GAAP and non-GAAP 2024 EPS by approximately $0.03 – $0.04.

Read also: Gilead Sciences completes acquisition of CymaBay Therapeutics for USD 4.3 billion

New Delhi: Denying to consider the clinical trial waiver proposal for the fixed dose combination (FDC) Vilanterol Trifenatate plus Umeclidinium Bromide Dry Powder Inhaler in capsule, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the drug major Sun Pharma Laboratories to conduct the bioavailability (BA) study of Vilanterol Trifenatate equivalent to Vilanterol 25mcg plus Umeclidinium Bromide equivalent to Umeclidinium 62.5mcg Dry Powder Inhaler in capsule.

This came after the drug maker Sun Pharma Laboratories presented the proposal along with comparative BA study protocol and justification for CT waiver before the committee.

Vilanterol trifenatate, a novel inhaled long-acting beta2 adrenoceptor agonist, is well tolerated in healthy subjects and demonstrates prolonged bronchodilation in subjects with asthma and COPD.

Vilanterol stimulates beta-2 receptors in the lungs. Beta-2 receptors mediate bronchodilation, so stimulation of these receptors leads to bronchodilation. Glycopyrronium blocks muscarinic M3 receptors. M3 receptors in lungs mediate bronchoconstriction, so blockade of these receptors leads to bronchodilation.

Umeclidinium is a long-acting muscarinic antagonist used as a long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD).

Umeclidinium blocks muscarinic M3 receptors. M3 receptors in lungs mediate bronchoconstriction, so blockade of these receptors leads to bronchodilation. Vilanterol stimulates beta-2 receptors in the lungs. Beta-2 receptors mediate bronchodilation, so stimulation of these receptors leads to bronchodilation.

At the recent SEC meeting for Pulmonary held on 5th March 2024, the expert panel reviewed the proposal presented by drug major Sun Pharma along with the comparative BA study protocol and justification for the CT waiver of the pulmonary FDC Vilanterol Trifenatate plus Umeclidinium Bromide Dry Powder Inhaler in capsule

After detailed deliberation, the committee recommended that the firm should conduct a BA study and the clinical trial waiver was not considered at this stage.

Accordingly, the expert panel suggested that the result of the BA study should be presented before the committee for further review of waiver of clinical trial study

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